LabCorp v. Metabolite Laboratories: The Supreme Court Listens,but Declines to Speak

Klein R. D. Kant J. A. Editorial , “Opportunity Knocks: The Pathologist as Laboratory Genetics Consultant,” Archives of Pathology and Laboratory Medicine 130, no. 11 (2006): 1603–1604.

See, e.g., Leonard D. G. B. , “Medical Practice and Gene Patents: A Personal Perspective,” Academic Medicine 77, no. 12, pt. 2 (2002): 1388–1391; Cho M. K. Illangasekare S. Weaver M. A. Leonard D. G. B. Merz J. F. , “Effects of Patents and Licenses on the Provision of Clinical Genetic Testing Services,” Journal of Molecular Diagnostics 5, no. 1 (2003): 3–8; Klein R. D. Letter , “Medical-Process Patents,” New England Journal of Medicine 356, no. 19 (2007): 753–754.

Laboratory Corp. of America v. Metabolite Labs., Inc., Order Granting Certiorari, 126 S.Ct. 543 (2005).

See, e.g., Rice v. Sioux City Memorial Park Cemetary, Inc. , 349 U.S. 70, 70–81 (1955).

Laboratory Corp. of America v. Metabolite Labs., Inc. , 126 S.Ct. 2921 (2006), dismissed as improvidently granted.

35 U.S.C. §§ 101–103 (2004).

35 U.S.C. § 101 (2004).

Diamond v. Diehr , 450 U.S. 175, 185 (1981).

Allen R. H. Stabler S. P. Lindenbaum J. , “Assay for sulfhydryl amino acids and methods for detecting and distinguishing cobalamin and folic acid deficiency,” U.S. Patent 4,940,658, filed November 20, 1986, and issued July 10, 1990.

Brief for Petitioner on Writ of Certiorari at 5, Laboratory Corp. of America v. Metabolite Labs., Inc. , 126 S.Ct. 2921 (2006), dismissed as improvidently granted.

Weissbach H. Taylor R. , “Role of vitamin B12 in Methionine Synthesis,” Federation Proceedings 25, no. 6 (1966): 1649–1656; Barker H. A. , “Biochemical Functions of Corrinoid Compounds,” Biochemical Journal 105, no. 1 (1967): 1–15.

Carmel R. Green R. Rosenblatt D. S. Watkins D. , “Update on Cobalamin, Folate, and Homocysteine,” Hematology (2003): 62–81; Schneede J. Ueland P. M. , “Novel and Established Markers of Cobalamin Deficiency: Complementary or Exclusive Diagnostic Strategies,” Seminars in Vascular Medicine 5, no. 2 (2006): 140–155.

See supra note 10, at 7.

Id., at 7–9.

Id., at 10.

Metabolite Labs. v. Laboratory Corp. of America , No. 99-Z-870 (D. Colo. November 21, 2001).

Metabolite Labs. v. Laboratory Corp. of America , 370 F. 3d 1354, 1365 (2004).

Id., at 1364.

See, Kesselheim A. S. Mello M. M. , “Medical-Process Patents – Monopolizing the Delivery of Health Care,” New England Journal of Medicine 355, no. 19 (2006): 2036–41.

See LabCorp, supra note 16.

See LabCorp, supra note 17, at 1372.

Order, February 28, 2005, Laboratory Corp. of America v. Metabolite Labs., Inc. , 125 S.Ct. 1413 (2005) (citing Diamond v. Diehr, 450 U.S. 175 [1981]).

Brief for the United States as Amicus Curiae on Petition for a Writ of Certiorari at 5–7, 15–19, supra note 5.

Conley J. M. Makowski R. , “Back to the Future: Rethinking the Product of Nature Doctrine as a Barrier to Biotechology Patents,” Journal of the Patent and Trademark Office Society 85, no. 5 (2003): 301–398, at 303–304.

Diamond v. Chakrabarty , 447 U.S. 303 (1980).

Diamond v. Diehr , 450 U.S. 175 (1980).

See Chakrabarty, supra note 25, at 309.

Kuehmsted v. Farbenfabriken , 179 F. 701 (7th Cir. 1910), cert. denied, 220 U.S. 622 (1911).

Parke-Davis & Co. v. H. K. Mulford & Co. , 189 F. 95 (S.D.N.Y. 1911), aff'd, 196 F. 496 (2d Cir. 1912).

Merck & Co. v. Olin Mathieson Chemical Corp., 253 F.2d 156 (4th Cir. 1958).

In re Bergstrom, 427 F.2d 1394 (C.C.P.A. 1970) (PGE, PGF).

See e.g., Amgen v. Chugai Pharmaceutical Co. , 927 F.2d 1200, 1206 (Fed Cir 1991) (“A gene is a chemical compound, albeit a complex one…”).

See Diehr , supra note 26.

Gottschalk v. Benson , 409 U.S. 63 (1972).

Parker v. Flook , 437 U.S. 584 (1978).

Arrhythmia Research Tech. v. Corazonix Corp. , 958 F.2d 1053 (Fed. Cir. 1992) (EKG system that utilizes programmed computer to analyze electrocardiographic signals is statutory subject matter); In re Alappat, 33 F.3d 1526 (Fed. Cir. 1994) (en banc) (digital processing circuitry programmed to generate antialiased oscilloscope tracing is statutory subject matter); State St. Bank & Trust v. Signature Fin. Group, 149 F.3d 1368 (Fed. Cir. 1998) (data processing system used to administer investment fund is statutory subject matter); ATT Corp. v Excel Commc'ns Inc., 172 F.3d 1352 (Fed. Cir. 1999) (computerized system for recording and billing long distance telephone calls that has ability to recognize called party's long distance carrier is statutory subject matter).

See Diehr , supra note 8, at 187.

State Street Bank & Trust Co. v. Signature Financial Group , 149 F.3d 1368.

See Diehr , supra note 8, at 189–191.

See State Street, supra note 38, at 1375. The omitted footnote reads, “Of course, the subject matter must fall into at least one category of statutory subject matter.”42. See Diehr , supra note 8, at 184.

Laboratory Corp. of Am. v. Metabolite Labs., Inc. , 126 S.Ct. 2921, 2927 (2006), dismissed as improvidently granted (Justice Breyer dissenting) (“But this case is not at the boundary. It does not require us to consider the precise scope of the ‘natural phenomenon’ doctrine or any other difficult issue. In my view claim 13 is invalid no matter how narrowly one reasonably interprets that doctrine.”)

Stabler S. P. Marcell P. D. Podell E. R. Allen R. H. , “Quantitation of Total Homocysteine, Total Cysteine, and Methionine in Normal Serum and Urine Using Capillary Gas Chromatography-Mass Spectrometry,” Analytical Biochemistry 162, no. 1 (1987): 185–196.

See LabCorp , supra note 44, at 2927 (Justice Breyer dissenting).

Id., at 2928.

Bogart M. , “Method for assessing placental dysfunction,” U.S. Patent No. 4,874,693, filed October 10, 1986, and issued October 17, 1989.

Barzo G. , “Lawsuit Heats Up over Patent on Common Prenatal Test,” American Medical News, January 12, 1998, at 1.

Brief for Respondents on Writ of Certiorari at 43–46, Laboratory Corp. of America v. Metabolite Labs., Inc., 126 S.Ct. 2921 (2006), dismissed as improvidently granted; Brief for the United States as Amicus Curiae on Petition for a Writ of Certiorari at 14, Laboratory Corp. of America v. Metabolite Labs., Inc., 126 S.Ct. 2921 (2006), dismissed as improvidently granted.

See generally, Duffy J. F. , “The Festo Decision and the Return of the Supreme Court to the Bar of Patents,” Supreme Court Review (2002): 273–342, particularly at 285 (“Because patent law is a fairly technical system of property rights, the Court has always behaved conservatively in the area, accepted doctrinal changes only incrementally, and looked to specialized actors in the patent system to take the lead in developing the law.”)

Klein R. D. , “Gene Patents and Genetic Testing in the United States,” Nature Biotechnology 25, no. 9 (2007): 989–990.

See Leonard , supra, note 2; Cho , supra, note 2.

Shattuck-Eidens D. M. Simard J. Durocher F. Mitsuuru E. Nakamura Y. , “Linked breast and ovarian cancer susceptibility gene,” U.S. Patent No. 5,709,999, filed June 7, 1995, and issued January 20, 1998.

See Klein , supra note 52.

See Leonard , supra note 2.

Murphy G. M. Schatzberg A. F. , “Method to determine the risk for side effects of an SSRI treatment in a person,” U.S. Patent No. 7,083,921, filed August 29, 2002, and issued August 1, 2006.

Kary B. Mullis won the 1993 Nobel Prize in Chemistry for his invention of the polymerase chain reaction (PCR).

Athena Diagnostics Web site, available at <http://www.athenadiagnostics.com/content/about/> (last visited September 21, 2007).

Athena Diagnostics, “List of Patents,” available at <http://www.athenadiagnostics.com/content/about/patents> (last visited September 21, 2007); the company also has patent rights to a number of immunologically related gene patents having less direct relationships with diseases.

See generally, Davies K. White M. , Breakthrough: The Race to Find the Breast Cancer Gene (New York: John Wiley & Sons, Inc., 1996).

ThermoFisher Scientific, Fisher Scientific Expands Presence in Molecular Diagnostics; Company to Acquire Athena Diagnostics from Behrman Capital and Purchase 9 Percent of Nanogen , News Release, March 16, 2006, available at <http://ir.thermofisher.com/phoenix.zhtml?c=89145&p=irol-newsArticle&ID=914979> (last visited September 21, 2007).

Myriad Genetics, “Genetic Testing for Hereditary Cancer,” available at <http:/www.myriad.com/products/cancerrisk.php> (last visited September 21, 2007).

Myriad Genetics, Myriad Genetics Reports Financial Results for Fiscal 2006 , News Release, August 22, 2006, available at <http://www.myriad.com/news/release/898035> (last visited September 21, 2007).

Pollack A. , “Rivals Laying Siege to Amgen's Near Monopoly in Anemia Drugs,” New York Times, December 23, 2005, at C1, Late Edition.

Klein R. D. Editorial , “The Pain Protective Haplotype: Introducing the Modern Genetic Test,” Clinical Chemistry 53, no. 6 (2007): 1007–1009.

Transcript of Oral Argument at 40, Laboratory Corp. of America v. Metabolite Labs., Inc., 126 S.Ct. 2921 (2006), dismissed as improvidently granted.